Recovering From Bariatric Surgery: the Effects of Early Initiated and Supervised Mobilization

Обзор

The aim is to investigate the effect of early initiated and supervised mobilization continued after discharge as management of postoperative pain and recovery following obesity surgery, including patient experiences, pain coping, physical functionality and quality of life.

Подробное описание

Study aims;

1. To investigate the effect of mobilization as pain management following obesity surgery. 2. To investigate patient experiences with mobilization and postoperative pain, including the influence of mobilization on patients' ability to cope with pain and an identification of facilitating factors and barriers towards early mobilization. 3. To assess the effect of mobilization on postoperative recovery, including the general physical activity level, physical function, and quality of life among patients discharged after obesity surgery.

The PhD study consists of two sub-studies. Study 1: Effect of early mobilization as pain management in patients recovering from obesity surgery. The study is a single center randomized controlled trial (RCT). Participants will be randomized with an allocation ratio of 1:1.

Study 2: Patient experiences with early mobilization and postoperative pain after surgery - An interview study Patients participating in both interventions (group A), will be invited to participate in two individual semi structured interviews.

Вмешательства

• Другое Intervention 1: Mobilization during hospitalization
  Surgical ICU Optimal Mobilization Score (SOMS) will be used to initiate early mobilization. SOMS consists of five levels of mobilization reaching from no activity to ambulation. Thirty minutes after PACU-arrival, the patient will be asked to do lower leg exercises. If this is possible, the patient will advance to the next level of mobilization. If not possible, level zero is recorded and the patient rests for another 30 minutes before attempting level one again. This continues until the patient
• Другое Intervention 2: Mobilization the first 4 postoperative weeks
  Intervention 2 will start the first weekday after discharge and continue for 4 weeks. Four supervised physical activity sessions and 8 sessions using telerehabilitation. The activities are low-intensity exercises (walking and lightly strength training using resistance bands) with progressed intensity throughout the weeks. The exercises will be individually progressed to meet the participant's level of activity, as it is important the participants benefit as much as possible from the intervention
• Другое Control group
  The control group receives standard care. Patients are mobilized to sit at the bedside before being transferred to the surgical ward. However, it is not used as prophylactic pain management nor is there a structured evidence based protocol with regard to mobilization. The control group will also be equipped with pedometers. They are encouraged to mobilize, and they receive a form in which they can write down mobilization for each hour. There is no planned supervised mobilization. As patients in

Первичные конечные точки

• Abdominal pain [Срок оценки: 24 hours post surgery]
• Physical function [Срок оценки: Baseline, 1 month postoperative and 6 months postoperative]

Вторичные конечные точки (9)

• Abdominal pain [Срок оценки: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative]
• Morphine equivalent consumption [Срок оценки: At baseline, during intervention 1, at discharge (at the end of intervention 1), 1 month postoperative and 6 months postoperative]
• Patient reported pain experiences [Срок оценки: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative]
• Pain self-efficacy [Срок оценки: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative]
• Pain catastrophizing [Срок оценки: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative]
• Postoperative nausea and vomiting [Срок оценки: During intervention 1, at discharge (at the end of intervention 1), 1 month postoperative and 6 months postoperative]
• Health related quality of life (SF-36) [Срок оценки: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative]
• Physical activity [Срок оценки: At baseline, 1 month postoperative and 6 months postoperative]
• Readmission [Срок оценки: 1 month postoperative and 6 months postoperative]

Критерии участия

Критерии включения

• The ability to read and understand the Danish language

Критерии исключения

• Preoperative dependence of walking aids
• Vision impairment
• Previous syncopes or epilepsy
• Admission to the intensive care unit after surgery
• Acute complications during hospital admission
• Patients are excluded at baseline if they have an oxygen saturation below 90% or a systolic blood pressure above 180 mmHg

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Esbjerg Hospital, University Hospital of Southern Denmark — Esbjerg

Публикации

• Christiansen NMN, Oxlund J, Dreyer P, Gram B. Recovery After Bariatric Surgery: The effects of Mobilization-A Study Protocol. Pain Manag Nurs. 2026 Jun;27(3):e486-e492. doi: 10.1016/j.pmn.2025.11.017. Epub 2025 Dec 19. PMID 41421861

Идентификаторы

NCT: NCT06222151 · 23/44737

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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